Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section (NCT07153601) | Clinical Trial Compass
CompletedNot Applicable
Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section
Indonesia46 participantsStarted 2025-02-07
Plain-language summary
This clinical trial was conducted to compare the effectiveness and safety of two medications-norepinephrine and phenylephrine-in treating low blood pressure (hypotension) that often occurs during spinal anesthesia for cesarean section (C-section) deliveries. Spinal anesthesia is commonly used during C-sections but can cause a drop in the mother's blood pressure, which may affect both the mother and the baby.
In this study, 46 pregnant women undergoing elective C-sections were randomly given either norepinephrine (4 mcg) or phenylephrine (50 mcg) when their blood pressure dropped. Researchers monitored their heart rate, blood pressure, and any side effects for 30 minutes after anesthesia.
The results showed that both drugs were effective in raising blood pressure. However, norepinephrine kept the heart rate more stable, while phenylephrine caused a noticeable slowing of the heart rate (bradycardia). Both drugs were safe and well tolerated.
This study suggests that norepinephrine may be a better option for managing low blood pressure during spinal anesthesia in C-sections, especially when maintaining heart rate and cardiac output is important.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 18-40 years
* Undergoing elective cesarean section
* Receiving spinal anesthesia
* Classified as ASA Physical Status II
* Stable baseline hemodynamics prior to anesthesia
* Not using inotropic, chronotropic, or vasoactive drugs before surgery
Exclusion Criteria:
* Emergency cesarean section
* Fetal distress
* Preeclampsia or eclampsia
* Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site)
* Known allergy to norepinephrine or phenylephrine
* Hemodynamic instability prior to vasopressor administration
* Withdrawal from study or refusal to participate
* Failure to develop post-spinal hypotension
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Systolic Blood Pressure (SBP) After Vasopressor Administration
Timeframe: Baseline to 2 minutes post-administration (T0-T2)